• Nenhum resultado encontrado

96

9 - REFERÊNCIAS

ANVISA. Resolução RDC n° 48, de 06 de outubro de 2009. Regulamento técnico para realização de alteração, inclusão, suspensão, reativação e cancelamento de medicamentos (Pós-Registro de Medicamentos). Brasil, Diário Oficial Da União, 2009.

ANVISA. Resolução RDC n° 31, de 12 de agosto de 2010. Requisitos para a realização dos estudos de equivalência farmacêutica e perfil de dissolução comparativo. Brasil, Diário Oficial da União, 2010a.

ANVISA. Farmacopeia Brasileira, volume 01, 5ª Ed. Brasília: Ministério da Saúde, 2010b. Disponível em http://farmacopeia.org.br/.

ANVISA. Resolução RDC n° 37, de 03 de agosto de 2011. Guia para isenção e substituição de estudos de biodisponibilidade relativa/bioequivalência. Brasil, Diário Oficial da União, 2011.

ANVISA. Resolução RDC n° 27, de 17 de maio de 2012. Requisitos mínimos para a validação de métodos bioanalíticos empregados em estudos com fins de regsitro e pós-registro de medicamentos. Brasil, Diário Oficial da União, 2012.

ANVISA. Resolução RDC n° 60, de 10 de outubro de 2014. Critérios para a concessão e renovação do registro de medicamentos com princípios ativos sintéticos e semissintéticos, classificados como novos, genéricos e similares. Brasil, Diário Oficial da União, 2014.

ANVISA. Resolução RDC n° 73, de 07 de abril de 2016. Procedimentos para mudanças pós registro e cancelamento de registro de medicamentos. Brasil, Diário Oficial da União, 2016.

A-Sasutjarit, R; Sirivat, A; Vayumhasuwan, P. Viscoelastic Properties of carbopol 940 gels and their relationships to piroxicam diffusion coefficients in gels bases. Pharmaceutical Research, 2005, v22, p.2134-2140.

97

Au, W.L.; Skinner, M.; Kanfer, I. Bioequivalence assessment of topical clobetasol propionate products using visual and chromametric assessment of skin blanching. Journal of Pharmacy & Pharmaceutical Sciences, 2008 11(1): 160-166.

Au, W.L.; Skinner, M.; Kanfer, l. Comparison of tape stripping with the human skin blanching assay for the bioequivalence assessment of topical clobetasol propionate formulations. Journal of Pharmacy & Pharmaceutical Sciences, 2010, 13(1): 11-20.

Barbero, A.M.; Frasch H.F. Pig and guinea pig skin as surrogates for human in vitro penetration studies: a quantitative review. Toxicology in Vitro, 2009, 23(1):1-13.

Bhaskar, K.; Ramachandran S.; Sridar S.K.; Rajarajan, A.T.; Ramkumar, A.; Sanathkumar, K.; Rao, G.S.; Ambu, J.; Dhanaraju, M.D.; Saravanan, M. Biopharmaceutical and pharmacodynamic studies on topically applied diclofenac gel available in Indian market. Bollettino Chimico Farmaceutico, 2004, 143(5): 208-210.

Boix-Montanes, A. Relevance of equivalence assessment of topical products based on the dermatopharmacokinetics approach. European Journal of Pharmaceutical Sciences, 2011, 42(3): 173-179.

Brady, A.C.; Davit, B.M.; Stier, E.M.; Conner, D.P. Survey of international regulatory bioequivalence recommendations for approval of generic topical dermatological drug products. The AAPS Journal, 2014.

Bruschi, M.L.; Jones D.S.; Panzeri, H.; Gremiao, M.P.; Freitas, O.; Lara, E.H. Semisolid systems containing propolis for the treatment of periodontal disease: In vitro release kinetics syringeability, rheological, textural, and mucoadhesive properties. Journal Pharmaceutical Sciences, 2007, Vol 96 (8), 2074-2089.

98

Caron, D.; Roussel, C.Q.; Shah, V.P.; Schaefer, H. Correlation beTween the drug penetration and the blanching effect of topically applied hydrocortisone creams in human beings. Journal of the American Academy of Dermatology, 1990, 23(3): 458-462.

Chang, R.K.; Raw, A.; Lionberger, R.; Yu, L. Generic development of topical dermatological products: formulation development, process development, and testing of topical dermatological products, The AAPS Journal,2012, Vol 15 (1), 41-52.

Chorilli, M.; Zague V.; Scarpa, M.V.; Lionardi, G.R. Influence of the vehicle in the in vitro release on the caffeine, Revista Eletrônica de Farmácia, 2007, Vol IV (1), 52-60.

Elewski, B. E. Percutaneous absorption kinetics of topical metronidazole formulations in vitro in the human cadaver skin model. Advances in Therapy, 2007, 24(2): 239-246.

EMA. Note for guidance on the clinical requirements for locally applied, locally acting products containing known constituents, 1995.

EMA. Guideline on the investigation of bioequivalence. C.F.M.P.F.H. CHMP), 2010.

FDA. Guidance for industry. Topical dermatologic corticosteroids: In vivo bioequivalence. Rockville: Food and drug administrartion. Center for drug evaluation and research (CDER), 1995.

FDA. Guidance for industry. Nonsterile semisolid dosage forms, scale-up and postapproval changes: Chemistry, manufacturing, and controls; in vitro release testing and in vivo bioequivalence documentation. Rockville: Food and Drug Administration. Center for Drug Evaluation and Research (CDER), 1997.

99

FDA. Topical dermatological drug product NDAs and ANDAs - In vivo bioavailability, bioequivalence, in vitro release, and associated studies. Rockville: Food and Drug Administration. Center for Drug Evaluation and Research (CDER), 1998.

FDA. Draft guidance for industry on topical dermatological drug product NDAs and ANDAs — In vivo bioavailability, bioequivalence, in vitro release and associated studies; Withdrawal. 2002.

FDA. Orange Book. Food and Drug Administration. Disponível em

http://www.accessdata.fda.gov/scripts/cder/ob/docs/queryai.cfm. Acesso em 12/12/2013.

Frans, T.J. Study #1, Avita Gel 0.025% vs Retin-A gel 0.025%, transcribed presentation, Advisory Committee for Pharmaceutical Sciences Meeting, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Rockville, MD, November 29, 2001; Presentation slides availabe at http://www.fda.gov/ohrms/dockets/ac/01/slides/3804s2_03_franz.pdf.

Ortiz, P.G.; Hansen, S.H.; Shah, V.P.; Sonne, J.; Benfeldt, E. Are marketed topical metronidazole creams bioequivalent? Evaluation by in vivo microdialysis sampling and tape stripping methodology. Skin Pharmacology and Physiology, 2010, 24(1): 44-53.

Guy, R.H.; Hadgraft, J. On the determination of drug release rates from topical dosage forms. International Journal of Pharmaceutics, 1990, 60, R1 - R3.

Harrison, L. I.; Stoesz, J.D.; Battiste, J.L.; Nelson, R.J.; Zarraga, I.E. A pharmaceutical comparison of different commercially available imiquimod 5% cream products. Journal of Dermatological Treatment, 2009, 20(3): 160-164.

Herkenne, C.; Alberti, I.; Naik, A.; Kalia, Y.N.; Mathy, F.X.; Préat, V.; Guy, R.H. In vivo methods for the assessment of topical drug bioavailability. Pharmaceutical Research, 2008, 25(1): 87-103.

100

Higuchi, W.I. Analysis of data on the medicament release from ointments. Journal of Pharmaceutical Sciences, 1962, V51, n8, p 802-804.

JAPAN. Guideline for bioequivalence studies of generic products for topical use. Minister of Health. Labour and Welfare, Pharmaceutical and Food Safety Bureau, National Institute of Health Sciences. 2003.

Jackson, D.B.; Thompson, C.; McComarck, J.R.; Guin, J.D. Bioequivalence (bioavailability) of generic topical corticosteroids. Journal of the American Academy of Dermatology, 1989, 20(5): 791-796.

Lademann, J.; Ilgevivius, A.; Zurbau, O.; Liess, H.D.; Schanzer, S.; Weigmann, H.J.; Antoniou, C.; Pelchrzim, R.V.; Sterry, W. Penetration studies of topically applied substances: Optical determination of the amount of stratum corneum removed by tape stripping. Journal of Biomedical Optics, 2006, 11(5): 054026- 054026s.

Lademann, J.; Jacobi, U.; Surber, C.; Weigmann, H.J.; Fluhr, J.W. The tape stripping procedure – evaluation of some critical parameters. European Journal of Pharmaceutics and Biopharmaceutics, 2009, 72(2): 317-323.

Lanke, S.S.S.; Kolli, C.S.; Strom, J.G.; Banga, A.K. Enhanced transdermal delivery of low molecular weight heparin by barrier pertubation. International Journal of Pharmaceutics, 2009, 365(1): 26-33.

Leal, L.B.; Araujo, T.P.; Chagas, S.C.C; Andrade, A.R.B.; Bedor, D.C.G.; Santana, D.P. Registro de medicamentos genéricos tópicos dermatológicos: Cenário Brasileiro e estudos para demonstração de bioequivalência. Revista Visa em Debate, 2017, 5(2): 3-12.

Leopold, C.S. Pharmacokinetic analysis of the FDA guidance for industry: "Topical dermatologic corticosteroid: in vivo bioequivalence". European Journal of Pharmaceutics and Biopharmaceutics, 2003, 56(1): 53-8.

101

Lippold, B.C. and Schneemann, H. The influence of vehicles on the local bioavailability of betamethasone-17-benzoate from solution-and suspension- type ointments. International journal of pharmaceutics, 1984, 22(1): 31-43.

Löffler, H.; Dreher, F.; Maibach, H.I. Stratum corneum adhesive tape stripping: influence of anatomical site, application pressure, duration and removal. British Journal of Dermatology, 2004, 151(4): 746-752.

Ma, L.; Wang, X.; Fu, Z.; Sun, A.; Gao, B. Comparison of release and penetration of tacrolimus ointment reference and trial formulation after dermal application to pigs by liquid chromatography–electrospray ionization tandem mass spectrometry. Biomedical Chromatography, 2013, 27(9): 1117 - 1122.

McKenzie, A. and Stoughton, R. Method for comparing percutaneous absorption of steroids. Archives of dermatology, 1962, 86(5): 608-610.

N’Dri-Stempfer, B.; Navidi, W.C.; Guy, R.H.; Bunge, A.L. Optimizing metrics for the assessment of bioequivalence beTween topical drug products. Pharmaceutical Research, 2008. 25(7): 1621-1630.

N’Dri-Stempfer, B.; Navidi, W.C.; Guy, R.H.; Bunge, A.L. Improved bioequivalence assessment of topical dermatological drug products using dermatopharmacokinetics. Pharmaceutical Research, 2009, 26(2): 316-328.

Narkar, Y. Bioequivalence for topical products — an update. Pharmaceutical Research, 2010, 27(12): 2590-2601.

Norris, D. A. Mechanisms of action of topical therapies and the rationale for combination therapy. Journal of the American Academy of Dermatology, 2005 53(1): S17-S25.

Olsen, E.A. A double-blind controlled comparison of generic and trade-name topical steroids using the vasoconstriction assay. Archives of Dermatology, 1991, 127(2): 197-201.

102

Parfitt, N.R.; Skinner, M.; Bon, C.; Kanfer, I. Bioequivalence of topical clotrimazole formulations: an improved tape stripping method. Journal of Pharmacy & Pharmaceutical Sciences, 2011, 14(3): 347-357.

Particle Sciences Technical brief, Development and validation of in vitro release testing methods for semisolid formulations. Particle sciences, Technical Brief, 2009, vol 10.

Pershing, L.K.; Nelson, J.L.; Corlett, J.L.; Shrivastava, S.P.; Hare, D.B.; Shah, V.P. Assessment of dermatopharmacokinetic approach in the bioequivalence determination of topical tretinoin gel products. Journal of the American Academy of Dermatology, 2003, 48(5): 740-751.

Pershing, L.K.; Silver, B.S.; Krueger, G.G.; Shah, V.P.; Skelley, J.P. Feasibility of measuring the bioavailability of topical betamethasone dipropionate in commercial formulations using drug content in skin and a skin blanching bioassay. Pharmaceutical Research, 1992, 9(1): 45-51.

Pershing, L.K. Bioequivalence assesment of three 0.025% tretinoin gel products: Dermatopharmacokinetic vs. clinical trial methods, transcribed presentation to the Advisory Committee for Pharmaceutical Sciences Meeting, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Rockville, MD, Noember 29, 2001; presentation slides available at

http://www.fda.gov/ohrms/dockets/ac/01/slides/3804s2_02_Pershing/index.htm;

Ponec, M. and Kempenaar, J. Biphasic entry of glucocorticoids into cultured human skin keratinocytes and fibroblasts. Archives of Dermatological Research, 1983, 275(5): 334-344.

Puavilai, S.; Krisadaphong, P.; Leenutaphong, V.; Asawanonda, P.; Akaraphan,

R.; Ploysangham, T.; Ruangkarnchanasetr, S.; Noppakun,

N.; Charuwichitratana, S.; Kulthanan, K.; Huiprasert, P.; Tresukosol, P.; Ophaswongse, S. Comparative study of the efficacy of topical corticosteroid:

103

five locally made and one brand name creams. Journal of the Medical Association of Thailand, 2002, 85(7): 789-799.

Sekkat, N.; Kalia, Y.N.; Guy, R.H. Biophysical study of porcine ear skin in vitro and its comparison to human skin in vivo. Journal of Pharmaceutical Sciences, 2002, 85(7): 789-799.

Selzer D.; Abdel-Mottaleb, M.M.A.; Hahn, T.; Schaefer, U.F.; Neumann, D. Finite and infinite dosing: Difficulties in measurements, evaluations and predicitons. Advanced Drug Delivery Reviews, 2013, 65(2): 278-294.

Sequira, J.; Berardi, M.; Chan, T.M.; Letarte, J.; Malchow, R.; Pramanick, B.; Wolkoff, H.N. Assessing equivalence of innovator and generic formulations of betamethasone dipropionate cream and ointment. Clinical Therapeutics, 1990, 13(6): 687-694.

Shah, V.P. Guidance for industry — topical dermatological drug product NDAs and ANDAs — in vivo bioavailability, bioequivalence, in vitro release and associated studies. US Dept. of Health and Human Services, 1998, Rockville: 1-19.

Shah, V.P.; Flynn, G.L.; Yacobi, A.; Maibach, H.I.; Bon, C.; Fleischer, N.M.; Franz, T.J.; Kaplan, S.A.; Kawamoto, J.; Lesko, L.J.; Marty, J.P.; Pershing, L.K.; Schaefer, H.; Sequeira, J.A.; Shrivastava, S.P.; Wilkin, J.; Williams, R.L. Bioequivalence of topical dermatological dosage forms –methods of evaluation of bioequivalence. Skin Pharmacology and Physiology, 1998, 11(2): 117-124.

Shah, V.P; Yacobi, A.; Radulesco, F.S.; Miron, D.S.; Lane, M.E. A Science based approach to topical drug classification system (TCS). International Journal of Pharmaceutics, 2015, 491(1-2): 21-25.

Soares K.C.C; Moraes M.V.; Gelfuso G.M.; Gratieri T, 2015a. Bioequivalence of dermatological topical medicines: the brazilian scenario and the challenges for health surveillance. Ciência & Saúde Coletiva,2015a, 20(11):3599-360.

104

Soares K.C.C.; Santos G.M.L.; Gelfuso G.M.; Gratieri T. An update of the brazilian regulatory bioequivalence recommendations for approval of generic topical dermatological drug products. The AAPS Journal,2015b, 17(6): 1517- 1518.

Spruance, S. L.; McKeough, M.B.; Cardinal, J.R. Penetration of guinea pig skin by acyclovir in different vehicles and correlation with the efficacy of topical therapy of experimental cutaneous herpes simplex virus infection. Antimicrobial Agents and Chemotherapy, 1984, 25(1): 10-15.

Stoughton, R.B. Are generic formulations equivalent to trade name topical glucocorticoids? Archives of Dermatology, 1987, 123(10): 1312.

Suzuki, T.; Uchino, T.; Miyazaki, Y.; Kagawa, Y. Release profiles of dexamethasone dipropionate from admixtures of steroid and heparinoid ointments prepared by different mixing methods. Chemical & Pharmaceutical Bulletin, 2011, 60(2): 260-266.

Thakker, K.D. and Chern, W.H. Development and validation of in vitro release testing methods for semisolid formulations. Dissolution Technologies, 2003, May, 10-15.

Trottet, L.; Owen, H.; Holme, P.; Heylings, J.; Collin, I.P.; Breen, A.P.; Siyad, M.N.; Nandra, R.S.; Davis, A.F. Are all aciclovir cream formulations bioequivalent? International Journal of Pharmaceutics, 2005, 304(1): 63-71.

Tsai, J.-C. Content and transdermal delivery of clobetasol 17-propionate from commercial creams and ointments. Journal of Food and Drug Analysis, 2002, 10 (1): 7-12.

Tsai, J. C.; Cheng, C.L.; Tsai, Y.F.; Sheu, H.M.; Chou, C.H. Evaluation of in vivo bioequivalence methodology for topical clobetasol 17‐propionate based on

105

pharmacodynamic modeling using chinese skin. Journal of Pharmaceutical Sciences, 2004, 93(1): 207-217.

Ueda, C.T.; Shah, V.P.; Derdzinski, K; Ewing, G. Flyinn, G; Maibach, H.; Marques, M; Ritting, H; Shaw, S.; Thakker, K; yacobi, A. Topical and Trandermal Drug Products. The United States Pharmacopeial Convention, Inc. Pharmacopeial Forum, 2009, v.35, p.750-764.

USP 37 - NF 32. The United States Pharmacopeia. Rockville: USP United States Pharmacopeial Convention, 2014. p 2400 e 2401.

Wei, H.; Chen, Y.; Xu, L.; Zheng, J. Percutaneous penetration kinetics of lidocaine and prilocaine in two local anesthetic formulations assessed by in vivo microdialysis in pigs. Biological & Pharmaceutical Bulletin, 2007, 30(4): 830- 834.

Wei, H.; Wang, S.Q.; Xu, F.; Xu, L.; Zheng, J.; Chen, Y. Topical bioequivalence of acyclovir creams using dermal microdialysis in pigs: a new model to evaluate bioequivalence for topical formulations. Drug Development and Industrial Pharmacy, 2012 38(7): 785-791.

Wiedersberg, S.; Leopold, C.S.; Guy, R.H. Bioavailability and bioequivalence of topical glucocorticoids. European Journal of Pharmaceutics and Biopharmaceutics, 2008, 68(3): 453-466.

Wiedersberg, S.; Leopold C.S.; Guy, R.H. Dermatopharmacokinetics of betamethasone 17-valerate: influence of formulation viscosity and skin surface cleaning procedure. European Journal of Pharmaceutics and Biopharmaceutics, 2009, 71(2): 362-366.

Documentos relacionados